Having come from a family in which I lost both of my brothers to hereditary nephritis, I saw dialysis as an opportunity to survive when I reached kidney failure in 1980. I was grateful for the opportunity to live that my brothers did not have, and took full advantage of dialysis therapy.

After a two-year adjustment period to home hemodialysis (HHD), I realized the limits to travel that dialysis imposes. My wife and my HHD partner and I had enjoyed travel extensively before I went on dialysis, so travel was a greatly valued activity. We had enjoyed many vacation trips to my wife’s family’s house on Dog Island, Florida, six miles off the Florida Big Bend area coast. I vowed that we would return to Dog Island where we had spent so many wonderful days before dialysis. Even though it was a very isolated place, I knew that everything was there that was necessary to do dialysis: water, power, and a drain. I calculated the electrical demand of the dialysis equipment and verified that the necessary amperage was available at the house. My dialysis equipment manufacturer advised that my R.O. machine could handle any potable water source.

So, we simply loaded the dialysis machines into a van, drove the three hundred miles to the Florida coast, and transferred the load to a boat that took us to the island. We spent many enjoyable days there during our summer vacation swimming, beachcombing, sailing, and visiting with guests as any couple might enjoy. It was very satisfying psychologically to realize that I had overcome one of the limitations of dialysis: the ability to travel independently.

However, there were other places we wanted to go where we would have no place to set up the dialysis equipment. While on Dog Island, I heard of a dialysis patient who traveled with the dialysis equipment in a van, dialyzing in campgrounds. I then realized that if I had a recreational vehicle (RV), I could load the dialysis equipment once, and then travel anywhere in North America. I had only to find an RV that I could fit the equipment into and to figure out the electrical and plumbing hookups. I accomplished that in a fairly short time, and we began traveling in our first RV in 1982.

Almost 17 years later we are now in our second RV, a much larger one, and we are still enjoying our travels with the independence and privacy of our own “home on wheels.” It would seem that we have extended the concept of home dialysis beyond a fixed home location. RV dialysis travel has certainly not been accomplished easily, as loading 500 lbs. of dialysis hardware, and up to 350 lbs. of consumable supplies requires some considerable effort. We have reduced the labor by employing simple machines like ramps and hoists, and by using a lawn tractor for moving equipment and supplies between house and RV.

The freedom and independence that RV dialysis travel has given me has contributed substantially to my rehabilitation, in my opinion. It has become a part of my lifestyle, a lifestyle that I believe is competitive with that of renal transplant recipients. So, the reader may imagine my shock and dismay when I learned from one of the major dialysis providers in October 1998 that they would not allow me to continue traveling and dialyzing in the RV if they were to become my provider.

Background

I had been supplied for many years by a DME company that decided to get out of the home hemodialysis equipment supply business. I sought service from a staff-assisted home hemodialysis facility in the Atlanta, Georgia, area as they had provided a substitute dialysis helper in the past when my wife was unavailable. Another reason I chose them is because if they were my HHD support facility, they could send a nurse to my home for required monthly visits rather than my having to go to the Atlanta area, which is 50 miles away. The facility was a dialysis unit of a large corporate provider. Staff members there were very positive about supplying and supporting me, with full knowledge that I traveled in the RV with dialysis. They told me that I would need only to provide them with a dialysis prescription from my nephrologist and credentialing information so that my nephrologist could have practice privileges in their unit. Upon completion of these two prerequisites my dialysis machines could be ordered.

When my nephrologist provided the requested information, prerequisites for service set by the staff assisted HHD facility in Atlanta were met, and I was told that my new dialysis machine would be ordered the last week of August 1998. I was told that it might take up to six weeks for the machine to arrive, but after six weeks, I still had not heard from the CEO of the dialysis facility. I called to ask the status of the machine, and was told that there was a problem. I was told that in the process of arranging for national technical support, the director of clinical services at the company’s national headquarters had learned of the plan to provide service to me as a patient who travels and dialyzes in an RV. The response of the director, according to the CEO, was absolutely not. She was told that I could not travel with dialysis in an RV because it is too dangerous and it is too much legal liability for the company. The CEO was very apologetic, saying that she was very sorry.

I was quite shaken by this news as it came as a great threat not only to my lifestyle, but also to my adjustment to dialysis and my state of rehabilitation as well. The experience did make me think that even on Method II HHD patient, I was still too dependent on a dialysis provider if my happiness and well being were so vulnerable. I asked a friend and fellow ESRD patient who is well known in the nephrology and patient community to speak with the medical director on my behalf. The friend asked me to prepare a document that would introduce myself and state my case, which I did.

In the meantime, I called the corporate director of clinical services to see if I could find out what the specific objections were. The director stated the following concerns: 1) Legal liability related to traveling with dialysis in an RV, 2) Concern about my dialyzing with various unknown water sources and concern about bacterial contamination, 3) Concern about machine calibration due to travel in the RV, and 4) Concern about access to emergency medical services.

In early November I sent the director of clinical services a written response to the concerns that she had expressed in our telephone conversation. To the issue of legal liability, I offered to sign a legal waiver that would protect the company from any legal actions on my part arising out of the RV travel. Regarding the unknown water sources, I responded that a “worse case” water treatment system was all that was needed, and as evidence of this, pointed out my successful record of almost 17 years of RV dialysis. I stated that a qualified water treatment provider could recommend such a system, but that I believed the system would require an R.O. and two large carbon tanks with total chlorine testing in between, all of which I currently had in place. Concerning machine calibration, I responded that modern dialysis machines use software calibration that is not subject to variances due to physical vibration. I further pointed out that dialysis machines are also alarmed On the issue of access to emergency medical services, I pointed out that most of the U.S. is covered by the 911 system, and that we have a cell phone in the RV for that very purpose. I stated that my plan for dialysis in the event that the technicians could not repair the dialysis equipment onboard the RV was 1) seek a transient treatment from a nearby dialysis facility (I carry medical records with me), 2) go to the emergency room of the nearest hospital that has dialysis, and 3) fly home to my backup facility.

I spoke with the director of clinical services again on November 20 and she said the major concerns were equipment calibration, AAMI standards, and provider responsibility for water treatment. She said that the lawyers were evaluating the AAMI water treatment guideline.

After this conversation I realized that I had better pursue another way of maintaining my independence and ability to continue my lifestyle of RV travel with dialysis in case my attempts to get service with this company failed. The logical alternative was to become my own Medicare supplier, so I began to seriously pursue this alternative. I learned that Medicare requires that prospective DME suppliers establish a business entity before they can apply for a Medicare supplier number. Thus, my wife and I organized a sole proprietorship registered on Jan. 1, 1999 as “Dialysis Consulting and Supply.” Establishing this business was surprisingly uncomplicated and inexpensive.

In dealing with the corporate dialysis provider I became quite frustrated by not having any one person who could keep me posted on the deliberations or dialog with me on the issues. No one seemed to want to take responsibility for talking with me, and I could get no information. So, on December 16, 1998, I wrote the medical director and expressed my frustration at not having anyone who would dialog with me on the issues.

At the request of the medical director, the QA director called me on December 28. She told me a little bit about the first corporate meeting held on November 9 to discuss my case. She said that all angles of the situation were discussed and debated, including the “moral and ethical” issue, and told me that another such meeting was scheduled for January 7, 1999. She said that the company was considering providing service to me as a pilot project, but that they did not want any other patient dialyzing in an RV. She said that she and the medical director were from “the old school” that believes in home dialysis and told me that she had 31 HHD patients when she was in Atlanta. Nonetheless, she continued, she and the medical director had to work with the company who still had technical and legal concerns. She further clarified that the company could serve me as a HHD patient in my home, but they could not allow me to travel in the RV with dialysis because they would be exposing themselves to legal liability by not following the AAMI guideline as they understood them. She also said that my offer to waive liability for RV travel was not acceptable to the lawyers. I should mention that my nephrologist was very supportive during all these deliberations. He wrote a letter to the medical director in which he expressed his opinion that I was technically competent to do dialysis in an RV, and that I was very conscientious about all aspects of performing safe dialysis. However, I could see no evidence that this letter had any influence on the company’s policies regarding RV dialysis.

I called the medical director on February 5, 1999, to ask about the status of the plan of service, and he said that the attorneys were still polishing some provisions of the plan that the director of technical services had prepared. The attorneys promised to have it to the medical director within a few days. The medical director did say that the local doctors (my nephrologist and the medical director of the local facility) would have to be willing to assume the legal responsibility for the plan and be willing to medically support it.

On February 12, 1999, the medical director faxed the plan to me, to my nephrologist, and to the medical director of the local facility. The corporate medical director stated that the company had spent a great deal of time reviewing my situation, and although my situation presented many difficult challenges, he believed the company could assist me. He then stated that the majority of this assistance would fall on the shoulders of the doctors, and that he would need for the doctors to assume responsibility for managing the program. He further stated that the company had determined that it was unsafe for me to lower the equipment from the second story window of my home, and that meeting AAMI water treatment standards for dialysis was necessary. He then proceeded to outline the program that consisted of the following elements:

The medical director of the local dialysis facility must accept me as a patient at the facility, and my nephrologist would see me there as a home dialysis patient.

The staff of the facility would evaluate my home situation to determine how the equipment could be moved into the motor home in some manner other than lowering it from a second story window.

When I wish to travel in the motor home, I would telephone my nephrologist and the staff at the dialysis facility to inform them of my destination. I would need to be specific as to the campsite location and would need to do this at least two weeks prior to departure. My nephrologist and/or someone from the facility staff would then be responsible for contacting someone, preferably a medical person, close to my destination who would obtain a sample from the water source at my specific destination. The sample would be sent for lab analysis, and based on the result, a determination would be made as to whether or not the pre-treatment for the RO is sufficient.

If a pre-treatment upgrade is required, the facility would arrange for a technician to perform an R.O. upgrade.

Assuming there are no objections to my proposed destination by either my nephrologist or the facility’s medical director, the facility would then arrange for a technician to move my dialysis machine into my motor home and check the equipment prior to departure.

When I return from my travels, the doctors would arrange for a technician to move the dialysis machine back into my house.

Continuing, the medical director of the company stated that “we anticipate the need to place certain reasonable geographic limitations on where Mr. Harper would travel and, of course, take certain legal precautions in connection with our written agreement with Mr. Harper.”

Reaction

First, I was a bit irritated that the plan described that I put the dialysis equipment “through a second story window.” I don’t know how they concluded this without a physical inspection. I could also see that the local doctors were being put on notice of their legal responsibility for the plan. Surprisingly, the doctors agreed to support the plan. Having someone else load and unload the dialysis equipment at first seemed to be a benefit as it would lift that burden off my wife and me. However we wondered how practical or convenient it would be to depend on someone else to do the job after we had spent so many years accepting that responsibility. Would they show up on schedule in a reliable way so that we could depart on a trip on schedule? Although our trips are pretty well planned, we wondered how tedious it would be to identify every campground we would visit on a trip. What if our plans changed enroute as they sometimes do? We also wondered about all the additional costs these measures would impose. And we wondered about the “geographical limitations” that were mentioned. We were accustomed to freely planning our travels as other Americans do. The language about analyzing the water and having a technician perform an “R.O. upgrade” made no sense to me. I had already advocated a “worse case” water treatment system in which two .5 cu. ft. carbon tanks would be placed in series with a worker tank and a backup tank with testing for total chlorine in between. Water treatment specialists had advised me that such a pretreatment system could safely handle the highest levels of chloramines currently found in municipal water systems in the country.

The second point in the plan stated that a home visit would need to be done. The local dialysis facility CEO and two technicians did the home visit on March 30, 1999. I took them on a tour of our motor home and they saw the dialysis machine and R.O. that were installed there (we usually leave the dialysis equipment in the motor home during the warm weather months). They observed the carbon treatment configuration I had in place and seemed to approve. I showed them some photographs of us loading the equipment into the RV using a system of wooden ramps. They also saw photographs of the dialysis machine being lowered to the ground from the upstairs porch. I then took them upstairs to examine the hoist with a winch and .25 inch steel aircraft cable. They seemed to conclude that the system I had in place was the most practical and labor saving. However, these conclusions were not stated so forthrightly in the written report to the company that was dated April 6, 1999. In that report the CEO of the dialysis facility stated it in this way: “I am concerned if technical staff would be required to assist in the moving of the machinery in the home. I do not believe that it would be safe for the technical department to move this equipment up and down the stairway for his travels. I think that there would be an increased incidence of back injury.”

I was both irritated and amused at the company’s attempts to identify, analyze, evaluate, and judge the methods by which we had been safely loading and unloading the dialysis equipment for the past 17 years.

On April 29, 1999, I received my business’s Medicare supplier number, a process that had taken nearly four months. At this point, my interests began to change. I could now supply myself with dialysis machines and supplies and receive Medicare payment, which meant that I would no longer be dependent on someone who could tell me I could no longer travel with dialysis in my motor home. With my own situation looking more secure, my principal interest now turned to persuading the company to agree to provide service to other patients like myself who also wanted to travel in an RV with dialysis. On the occasions when I had told the company that I had applied for a Medicare supplier number, they replied that they had never heard of such a thing, and that they were certain that a patient could not obtain a Medicare supplier number. Thus, they discounted this idea and pursued the development of the plan of service as well.

The company medical director’s inquiries about the status of the plan resulted in a call from one of the company lawyers, a delightful young lady with whom, for the first time, I could freely and logically discuss the issues involved. Although she made it clear that she represented the company, she seemed to want to help me and did so by presenting my arguments to the other company officials. She apologized for the delays, and acknowledged that I had been more than patient. I discussed the principal issues with her: I reiterated my views and she promised to discuss this with the other company officials and call me a week later which she did.

In her June 4, 1999 call, the attorney told me there might be some movement on the water treatment issue based on the information I had provided concerning Appendix B2 of the AAMI guideline. She stated that their plan might call for my nephrologist to sign off on the “worst case” water treatment system that I had been advocating. The nephrologist would make this note in the chart. I saw this as another red flag of legal liability that they would be waving in front of my nephrologist, even though he already had that responsibility.

She continued, however, that there was no movement on the issue of moving the machines. She said the concern was that in the process of moving the machines, I might turn them loose or drop them and that they might hit and injure a third party who would then have access to the company’s “deep pockets.” I questioned that if I backed my Honda automobile down the driveway and injured someone, could that person sue Honda Motors? She replied no, but in my situation the liability of the company could be based on the fact that my moving the machines might be considered beyond the scope of what a home dialysis patient should be doing, and that it “looks bad.” I was quite alarmed at this view as I felt it demonstrated a lack of understanding and support for home dialysis. I argued that home dialysis patients are taught to take a lot of responsibility for their own care and are encouraged to do all for themselves that they are capable of doing. I also told her that I had requested that the major patient organization develop a general policy on access to care that would include RV dialysis. I reported that the organization had decided to poll the major providers to determine what their policies were on this issue.

In further discussions with the company attorney on June 11, she told me that the company was now considering providing me with two sets of machines so that moving the machines would no longer be an issue. I again was concerned about the cost of this plan and how it would affect the company’s willingness to provide this service to other patients. I inquired about the local CEO’s concern about the financial deficit that this plan would create, and pointed out that the CEO stated that she is financially responsible for her own facility. The attorney responded that a deficit would be shown on the company’s national budget for this plan, but that everyone in the company would be aware of it and accept it. I later confirmed this understanding with the local facility CEO.

July 1,1999, was another milestone for my DME company. On that date I filed my first claim for home hemodialysis supplies.

The company lawyer called me on July 12,1999, and told me that there would be a conference call of several of the corporate principals within the next few days. She said that the company medical director had stated several points in favor supporting RV dialysis, but that he also agreed that the legal issues were important, too. I was disappointed to hear this because I had hoped that the doctor would remain a strong patient advocate. I requested that the legal liability issue be clarified. Is the liability concern based on possible injury to a third party, or based on my moving the machines being outside the scope of what a dialysis patient should be doing, or both? I also asked for clarifications on the issue of geographic restrictions on my travels, and asked that the plan clearly state a strong commitment to provide priority equipment technical support to me. I had been told that the company already had a policy of giving priority technical service to home patients, but I wanted this to be in writing in the plan. I again expressed my concern that the plan be made available to all qualified patients who wanted to perform RV dialysis travel.

August 4, 1999, was a day of glory for my wife and me. On this date, Medicare made an electronic funds transfer payment to our DME business bank account. This was payment for our first claim for ESRD supplies for the month of July 1999. This payment was final proof of the success and viability of our DME business which we had created to supply me with dialysis equipment and supplies, and final proof that I had been successful in maintaining my independence and freedom to continue the RV travel as a HHD patient.

I phoned the company attorney on September 17, and she told me that the plan of service and legal agreement was completed and ready to be sent out to the various corporate principals for approval. She told me that the process of approval would take one to two weeks.

I phoned the company attorney on October 1, two weeks after the document was to be finished. I left a message. Not receiving a reply, I called again in a couple of days. The attorney finally returned my call on October 12. She wanted to promise to call me on October 19, a week hence, to report on progress, but couldn’t promise that a resolution would be reached by then. I tried to get her to clarify what the status was of the document and the corporate principals’ responses, but she did not want to get into the details.

The company attorney called on October 19 as promised, and I learned why she had been so evasive on October 12. She told me that her supervisor had informed her that there was a problem with the plan to give me a second set of machines for the RV. She explained that the problem was the U.S. Fraud and Abuse law. She said that if the company gave me the machines, it could appear to be a bribe to solicit me as a patient. It would amount to an inducement of a referral, which is prohibited under the law. She wanted to know if I could afford $750.00 per month rental for the second set of dialysis machines. If so, the plan could proceed.

I asked if she could send me the draft of the legal agreement I would have to sign to receive service. She said she could not send it to me, but she went over the agreement with me verbally. The agreement requires me to release the company from all legal liability arising out of the agreement except for gross negligence and intentional wrongdoing. I would assume all risks arising out of the RV travel. The release would also extend to my estate, and my wife must sign the agreement. The agreement would be renewable every six months. I must agree to follow all rules of the clinical staff. I will not do RV dialysis unless all aspects of it are approved by the clinical staff. I will give the clinical staff 14 days notice before making any trip in the RV. I must agree to cooperate with the clinical staff. If I come out of compliance with the clinical staff’s rules, I will have a thirty-day “cure” period in which I must come back into compliance in order to continue the agreement. Without a physician’s order approving my destination and accepting legal liability for water treatment, I would be restricted to certain unnamed geographical destinations. I must have homeowner’s and RV insurance. I must agree to indemnification provisions – reimburse the company if they get sued for something related to the RV travel. Finally, I must agree to confidentiality of the agreement, except for “Exhibit D.” “Exhibit D” states something to the effect: The company has entered into this agreement as a pilot project. The company recognizes the rehabilitative potential of RV travel, and realizes how much RV travel has meant to the Harpers, and wants to help them continue the RV travel. The company has entered into the pilot project to learn more about RV dialysis and how it may be provided for other patients. The aforementioned statement is all that I am allowed to write about the agreement.

After being distracted by other pressing matters, but after giving much thought to the fraud and abuse law issues, I phoned the company attorney on November 12. I attempted to refute the application of the fraud and abuse law to the facts of my situation. First, I argued that since this would be a criminal matter, intent would be necessary. I pointed out that intent was lacking – the company obviously did not intend to bribe me for my business. I argued that the facts of the case over fifteen months would demonstrate that the company did not want my business. Second, I argued that the facts of the case clearly show that the company had not been seeking my business; on the contrary, the facts show that I had been ardently seeking service from the company. Finally, I argued that for the fraud and abuse law to apply in this case, the prosecution would have to demonstrate that the company benefited from gaining me as a patient. I pointed out that if they gave me a second set of machines, the service would cost them more than they would make. The attorney acknowledged that at least the third argument might have merit. I told her I thought her supervisor’s application of the fraud and abuse law to the facts of this situation was cynical and that it created a vicious circle which was absurd: that I had been safely doing RV dialysis for 17 years, but that in order for the company to address their legal risk concerns they would give me a second set of machines, but then because of the fraud and abuse law they would have to charge me for them. At this point, I told her that I felt confident in my ability to provide service for myself, and that it was finally obvious to me that the company would never agree to provide service to me. Therefore, I said, I intended to close the matter, and stated that my only remaining concern was that RV dialysis be made available to other patients. Surprisingly, she did not want to accept that outcome. She stated that she had put a lot of work into the legal agreement, and that she was a part of a company that serves dialysis patients, and that she did not want to accept that the company could not serve me. She told me that she would talk to her boss and get back to me. Like the medical director, she was a decent person whose human instincts told her to try to help me, but could not because she was a cog caught up in the bureaucratic machinery of the big company.

Also during this phone call, the attorney stated that she believed that the only reason the company could not serve me was because of the hoist that I used to lower the machines from a second story porch. Therefore, she thought that the service could be provided to other patients who wanted to do RV dialysis, provided the facts of their case were not the same as mine. When I questioned the company’s view that the hoist was not safe, I asked if a qualified engineer had given an expert opinion that the hoist was not safe. She pointed out that the local company staff had made a home visit. I replied that I had a copy of the letter the staff sent to the company after the home visit, and nowhere in the letter did it say that the hoist was not safe, or that it was inadequate. I asked whether or not the company could serve me if my wife and I would lift the machines up and down the indoor stairs without using the hoist. She said she would have to call me back. That was the last I heard from the company.

Conclusion

So, what did I learn from this long attempt to get home hemodialysis service from this large company? First, I was very surprised at the lack of understanding the company had for some of the technical and regulatory dialysis issues. The company director of clinical services apparently thought that bacterial levels were an issue of the water supply whereas, in fact, they are an issue of proper machine disinfection. I would have thought that personnel at the company’s headquarters would have a deep understanding of technical issues in dialysis. The company also was not aware that the AAMI water treatment standards could be modified to meet individual circumstances by order of a physician until I pointed that out to them.

Second, I believe the company demonstrated an alarming lack of understanding of the philosophy and rehabilitative potential of the home hemodialysis modality. I am not alone in having traveled successfully with dialysis equipment in a motor home. It is something that a few of us have done for many years. The company failed to recognize and value the rehabilitative contribution this ability to travel can make to a patient’s well being. Their legal concerns obviously overshadowed their support of me as a traveling dialysis patient. They seemed to be uncomfortable allowing me to exercise the control over my treatment that home hemodialysis had always afforded me. I believe they viewed me as they would an in-center patient for which they felt responsible for creating a risk-controlled environment. They seemed to have what I would call a “cookie cutter” mentality. Individualized treatment based on the patient’s individual needs did not seem to be an option.

Third, the company seemed like a lumbering giant; one that stumbled over patients like myself in its efforts to provide standardized dialysis treatments on a large, efficient scale. It was very frustrating trying to communicate with a large bureaucracy in which no one would accept responsibility or make a decision. In the beginning, I was quite naïve in believing that if I could just talk with the company’s medical director, he could bring reason, wisdom, and action to my problem. I soon learned that he was just another cog in the machine. He wanted to advocate my position, but his was only one voice among many, and that voice lost out to the legal and risk management viewpoint. The loss of physician control of medicine was clearly demonstrated here. What should have been a fairly straightforward arrangement between a nephrologist, dialysis provider, and patient to assist a patient in reaching his highest level of independence and rehabilitation became a 13-month conundrum of bureaucratic stonewalling. It is notable that the local dialysis facility, focused on helping and serving patients, initially agreed to serve me, but was stopped by the company headquarters.

Finally, I’m afraid that my experiences bode poorly for both home hemodialysis and patient well-being if dialysis services are to continue to be provided by mega corporations. Hopefully, the trend can be reversed and individual patient needs can be met on a smaller scale by facilities that are controlled by staff and physicians whose interests are focused on their patients. I am very sad at the prospects of my fellow home hemodialysis patients concerning RV dialysis, but ironically, the experience benefited me personally. I had long entertained the fantasy of obtaining a Medicare supplier number and supplying myself on home hemodialysis as the ultimate in patient independence. This threat to my life style and rehabilitation was the catalyst that finally spurred me to take action to make this dream a reality. So, for that I must thank this big dialysis provider.